Population Council #728

Principal Investigator(s):George Creasy, MD
Objective:A Phase 1 Trial to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PC-6500 (Griffithsin [GRFT] in a Carrageenan Gel) in Healthy Women   Last updated May 15, 2021
Prevention Option(s):Microbicides
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionIn the randomized period, duration of treatment will be 14 days; each of the 30 subjects will self-administer Griffithsin Gel once daily for 14 consecutive days, with 5 doses administered under clinical supervision and the remaining 9 doses administered at home.
Mode of DeliveryGel
Official Code: NCT02875119
Start Date
End Date
October 6, 2017
September 5, 2018
Age range: 18 Years ↔ 49
Population:Cisgender Women